Nanjing Leads Biolabs Co., Ltd. (Leads Biolabs) reported updated Phase II results for its PD-L1/4-1BB bispecific antibody LBL-024 (Opamtistomig) combined with chemotherapy as an initial treatment for non-small cell lung cancer (NSCLC) at the 2026 World Conference on Lung Cancer.

A total of 63 previously untreated NSCLC patients were enrolled (31 non-squamous, 32 squamous); more than 90% had stage IV disease. PD-L1 tumour proportion score (TPS) ≥1% was observed in 35.50% of non-squamous and 43.80% of squamous cases, well below the typical 60-70% rate in the wider population.

Key efficacy outcomes (62 efficacy-evaluable patients): • Overall population – Objective Response Rate (ORR) 71.00%, Disease Control Rate (DCR) 95.20%, six-month progression-free survival (PFS) 70.60%. • Squamous NSCLC – ORR 87.10%, DCR 96.80%, six-month PFS 86.70%. – PD-L1-positive: ORR 84.60%, six-month PFS 84.60%. – PD-L1-negative: ORR 88.20%, six-month PFS 87.40%. • Non-squamous NSCLC (PD-L1 TPS ≥1%) – ORR 81.80%, DCR 100.00%, six-month PFS 90.00%; favourable activity also noted in patients with TPS 1-49%.

Safety resembled that of established PD-L1 antibodies combined with chemotherapy, and no new safety signals emerged.

LBL-024 is the first PD-L1/4-1BB bispecific antibody to reach Marketing Authorisation review. Clinical development spans 14 solid-tumour indications, and approximately 800 patients have received the drug across seven tumour types, including multiple immunologically “cold” cancers. The programme has secured Breakthrough Therapy Designation (China NMPA), Fast Track status (US FDA) and Orphan Drug designations in the United States and European Union.

Leads Biolabs is advancing a Phase III trial of LBL-024 as a first-line therapy for NSCLC, aiming to translate the dual-target immune-synergy mechanism into broader and more durable clinical benefit.